Transvascular access device and method

ABSTRACT

Transvascular access devices and methods for transvascular access are provided. The transvascular access devices can include a guidewire lumen and a guide tube and stylet disposed in a second lumen. The guide tube can be used to control the orientation of the stylet and provide additional support for the stylet. The methods include providing a second entry point in a vessel of a patient remote from a first entry point. A vascular catheter can enter the vascular system of a patient at a first entry point and be advanced to a second entry point. A guide tube can be advanced out the second lumen of the vascular catheter with a stylet advanced out of the guide tube to pierce the vessel wall and skin of the patient at the second entry point. A catheter can be introduced to the vascular system at the second entry point.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/653,182, filed May 30, 2012, the disclosure of which is incorporatedby reference as if fully set forth herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

The present invention relates to methods and devices for providingtransvascular access to blood vessels. Prior devices and methods havebeen described for providing, e.g., access for placing a central venousline in the jugular vein using a remote vascular entry point, such asthe femoral vein. In those prior approaches, a steerable catheter with abent or bendable tip is guided from the femoral or other entry point tothe desired central venous line entry point in the jugular vein. The tipof a sharp wire or stylet is then advanced out of the catheter andthrough the vessel wall and skin of the patient, and the central venousline is then inserted over the wire or stylet. More details of theseprior devices and methods may be found in U.S. application Ser. No.12/861,716 (filed Aug. 23, 2010); U.S. application Ser. No. 12/366,517(filed Feb. 5, 2009); and U.S. application Ser. No. 11/424,131 (filedJun. 14, 2006), the disclosures of which are incorporated herein byreference.

SUMMARY OF THE DISCLOSURE

The present invention provides new devices and methods for providing asecond entry point to a vessel remote from a first entry point. Oneaspect of the invention provides a system for providing a second entrypoint in a vessel remote from a first entry point, including thefollowing elements: a vascular catheter having first and second lumens,the first lumen being adapted to receive a vascular guidewire; a guidetube disposed in the second lumen, the guide tube having a distal endwith a preformed curve; a stylet disposed in the guide tube, the stylethaving a sharp distal tip adapted to pierce vascular tissue, muscle andskin; a guide tube actuator operatively connected to the guide tube orvascular catheter, the guide tube actuator configured to producerelative movement between the guide tube and the vascular catheter; anda stylet actuator operatively connected to the stylet, the styletactuator having a stylet advancement mechanism. In some embodiments, thesecond lumen extends in a curve at its distal end.

In some embodiments, the guide tube actuator and the stylet actuator aresupported by a handle at the proximal end of the vascular catheter. Insome such embodiments, the guide tube actuator has a slider movablydisposed in the handle and operatively connected to the guide tube orvascular catheter. In some embodiments the slider is operativelyconnected to the guide tube and is configured to advance the guide tuberelative to the second lumen of the vascular catheter. In someembodiments the slider is operatively connected to the vascular catheterand configured to move the vascular catheter relative to the guide tube.

In some embodiments the handle includes a first wing and a second wingon opposing sides of the handle with the preformed curvature of theguide tube oriented to extend perpendicular relative to a plane definedby the first and second wings. In some embodiments the slider is on thesame side of the handle as the side that the preformed curvature of theguide tube is oriented to extend towards.

In some embodiments, the sharp distal tip includes a conical shaped tip.In some embodiments the sharp distal tip includes a faceted tip.

In some embodiments, the stylet actuator includes a spring. In some suchembodiments, the stylet actuator can also have a spring loading actuatorand a spring release actuator.

Another aspect of the invention provides a method of providing a secondentry point in a vessel of a patient remote from a first entry point.The method may include the following steps: deploying a vascularguidewire into the vessel from the first entry point toward the secondentry point; inserting the guidewire into a first lumen of a vascularcatheter; advancing the vascular catheter over the guidewire from thefirst entry point toward the second entry point; advancing a guide tubeout of a distal end of a second lumen of the vascular catheter;directing a distal opening of the guide tube towards a wall of thevessel at the second entry point; and advancing a stylet out of thedistal end of the guide tube, through the vessel wall and skin of thepatient.

In some embodiments directing the distal opening of the guide tubetowards the wall of the vessel at the second entry point includesplacing the distal opening of the guide tube against the wall of thevessel at the second entry point.

Some embodiments also include the step of inserting a device over thestylet and into the vessel at the second entry point.

In some embodiments, the guide tube has a preformed curve at its distalend, and the step of advancing the guide tube includes the step ofpermitting the guide tube distal end to assume its preformed curve asthe guide tube distal end is advanced out of the distal end of thesecond lumen of the vascular catheter.

In some embodiments, the second lumen of the vascular catheter extendsin a curve at its distal end, and the step of advancing the guide tubeincludes the step of engaging a camming surface in the curve of thesecond lumen with a distal end of the guide tube to advance the distalend of the guide tube away from a longitudinal axis of the vascularcatheter and toward a wall of the vessel.

In some embodiments, the step of advancing the guide tube includes thestep of moving an actuator in a handle at the proximal end of thevascular catheter. In some embodiments moving the actuator advances theguide tube relative to the second lumen of the vascular catheter. Insome embodiments moving the actuator proximally retracts the vascularcatheter relative to the guide tube

In some embodiments, the step of advancing the stylet includes the stepof operating a stylet actuator in a handle at the proximal end of thevascular catheter. In some such embodiments, operation of the actuatorreleases a spring. The method may also include the step of loading thespring prior to the step of releasing the spring.

Some embodiments include verifying the positioning of the guide tubeafter placing the distal opening of the guide tube against the wall ofthe vessel at the second entry point prior to advancing the stylet.Verifying can include using fluoroscopy to verify the position of theguide tube.

Some embodiments include adjusting the orientation of the handle priorto advancing the guide tube to orient the vascular catheter such thatwhen the guide tube is advanced out of the distal end of the secondlumen, the guide tube extends from the vascular catheter towards theskin of the patient at the second entry point.

In some embodiments the first entry point is selected from the groupconsisting of: the femoral vein and femoral artery, and the second entrypoint is selected from the group consisting of: the internal jugularvein, subclavian vein, carotid artery, axillary artery, and subclavianartery.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a schematic drawing illustrating the insertion of a guidewireextending from a patient's femoral vein to the jugular vein.

FIG. 2 is a perspective view of a transvascular access device accordingto an embodiment of the invention.

FIG. 3 is a side view of the device of FIG. 2 mounted on a guidewire.

FIG. 4A is a perspective view of a cross section of the device of FIG.2.

FIG. 4B is a bottom view of a cross section of the device of FIG. 2.

FIG. 4C is a perspective view of a cross section of the bottom of thedevice of FIG. 2.

FIG. 5A is a side view of the device of FIG. 2 with the stylet covertube advanced and the stylet actuator loaded.

FIG. 5B is a side view of the device of FIG. 2 with the stylet deployed.

FIG. 6A is a cross-sectional schematic view of the device of FIG. 2 withthe stylet deployed.

FIG. 6B is a cross-sectional schematic view of the device of FIG. 2being advanced over a guidewire in a vessel, such as a vein.

FIG. 7A is a cross-sectional schematic view of a device in accordancewith an embodiment with the stylet deployed.

FIG. 7B is a cross-sectional schematic view of a device in accordancewith an embodiment being advanced over a guidewire in a vessel, such asa vein.

FIG. 8 is a cross-sectional schematic view of the device of FIG. 2 withthe stylet cover tube advanced to a desired exit point within thevessel.

FIG. 9 is a cross-sectional schematic view of the device of FIG. 2 withthe stylet advanced through the vessel wall and skin of the patient.

FIGS. 10-12 are cross-sectional schematic views of the device of FIG. 2with the stylet being prepared for use in inserting another device intothe vessel.

FIG. 13 is a cross-sectional schematic view of another device insertedinto the vessel.

FIG. 14 is a cross-sectional schematic view of the device of FIG. 2 withthe stylet cover tube advanced to a desired exit point within thevessel.

FIG. 15 is a cross-sectional schematic view of the device of FIG. 2 withthe stylet advanced through the vessel wall and skin of the patient.

FIG. 16 is a cross-sectional schematic view of the device of FIG. 2 withthe stylet being prepared for use in inserting another device into thevessel.

FIG. 17 is a cross-sectional schematic view of another device insertedinto the vessel.

FIG. 18A is a side-view of a faceted stylet tip in accordance with anembodiment. FIG. 18B is an isometric view of the device of FIG. 18A.FIG. 18C is an end view of the sharp distal point of the device of FIG.18A.

FIG. 19A is a side-view of a conical stylet tip in accordance with anembodiment. FIG. 19B is an isometric view of the device of FIG. 19A.

FIG. 20A is a fluoroscopic image of a device in accordance with anembodiment in an animal blood vessel.

FIG. 20B is an image of a device in accordance with an embodiment afterpuncturing an animal blood vessel.

DETAILED DESCRIPTION

FIG. 1 shows a patient whose femoral vein 12 has been accessed by theModified Seldinger Technique. A general use guidewire 30 typicallymeasuring about 0.035 inches in diameter has been passed through avascular sheath 20 and ultimately positioned in a jugular vein 14 in thevicinity of a desired exit and reentry site (or pass-through site) 15for central vein access.

FIGS. 2-17 show various embodiments of access devices. FIGS. 2-17 arenot drawn to scale to facilitate the illustration of the device 40. Avascular catheter 42 extends from a handle 44. The length and diameterof catheter 42 depend on the distance between the remote first entrypoint and the desired second entry point. For example, if the remoteentry point is the femoral vein and the desired second entry point isthe jugular vein, as shown in FIG. 1, the vascular catheter may have alength of about 1 meter and may have a diameter of around 7 french(0.092 inches). The catheter may have a tapered or conical tip 47.

In some embodiments, the vascular catheter has an optional guidewirelumen. In the embodiments shown in FIGS. 2-17, the guidewire lumen 46 isconfigured as a rapid exchange (RX) guidewire lumen for receiving aguidewire 30. In embodiments in which the remote entry point is thefemoral vein and the desired second entry point is the jugular vein, theguidewire 30 may be a 0.035 inch guidewire. In some embodiments theguidewire 30 is advanced through the handle 44 of the access device 40.In some embodiments the guidewire 30 can be introduced into theguidewire lumen 46 using an introducer kit (not shown). The guidewirecan be positioned adjacent to the desired second entry point in thepatient's vascular system. The vascular catheter can be advanced overthe guidewire before or after the guidewire is positioned adjacent tothe desired second entry point.

The handle 44 can include a top portion 45A and a bottom portion 45B.FIG. 4A illustrates a top of the top portion 45A of the handle 44. FIG.4B illustrates a bottom of the top portion 45A of the handle 44. FIG. 4Cillustrates a bottom portion 45B of the handle 44. The top portion 45Aand bottom portion 45B can engage to form the handle 44. The handle 44also includes wings 48 on opposing sides of the handle 44. The wings 48can be used to apply a distal force to the vascular catheter from thehandle.

In addition to the guidewire lumen 46, device 40 has a stylet lumen 50extending from the handle 44 to an opening 54 toward the distal end ofthe catheter. In some embodiments, the stylet lumen curves at its distalend to form a camming surface 56. A curved stylet lumen with a cammingsurface 56 is shown in FIGS. 6A and 6B. The camming surface 56 canprovide additional structural support to a guide tube or cover tube 60when it is in an advanced position. A stylet 58 is slidably disposedwithin the cover tube 60.

In some embodiments the stylet lumen 50 does not have a curved cammingsurface. For example, the stylet lumen 50 can be substantiallycylindrical as illustrated in FIGS. 7A and 7B.

The stylet 58 (formed, e.g., from Nitinol with a diameter of 0.014inches) enclosed by the cover tube 60 (such as a 0.025 inch diameterNitinol hypotube) extends from an actuator 51, 52 and 53 in the handle44 toward the distal end of device 40. In some embodiments, cover tube60 has a preformed curve, such as a 90 degree curve, at its distal end.The optional camming surface 56 can promote the curvature of the covertube 60.

Stylet 58 has a sharp distal point 62 adapted to penetrate tissue, suchas blood vessels, muscle, and skin. The sharp distal point can be partof a tip design having various dimensions and shapes. In someembodiments a faceted tip 80 is used. FIGS. 18A-18C illustrate variousviews of the faceted tip 80. The illustrated faceted tip 80 includesthree flat surfaces that intersect to form the sharp distal point 62. Insome embodiments a conical tip 90 is used. FIGS. 19A-19B illustratevarious views of the conical tip 90. The illustrated conical tip 90forms an angle of about 10° with the shaft of the stylet 58.

In use, e.g., to provide a jugular vein second entry point using thefemoral vein as a first entry point, catheter 40 is inserted into thefemoral vein over the guidewire 30 and advanced adjacent to the desiredexit point 65 (FIG. 8) in the jugular vein 64 under fluoroscopicguidance with the stylet and cover tube in a retracted position, asshown in FIG. 6B, and the distal opening of the stylet lumen is orientedtoward the desired exit point 65 in the vein wall 66. In someembodiments the catheter tip 47 includes a radiopaque marker 49 visibleunder fluoroscopy as shown in FIG. 8. The radiopaque marker 49 can beembedded in the catheter tip 47. The radiopaque marker 49 is illustratedas a ring in FIG. 8; however, other shapes and geometries can be used.In some embodiments the shape of the radiopaque marker can be selectedto facilitate fluoroscopic identification of the location andorientation of the catheter tip 47. Examples of radiopaque markermaterials include gold, platinum, platinum-iridium, and otherbiocompatible radiopaque materials.

The cover tube 60 is then advanced out of opening 54 by moving a slidebutton 51 proximally in handle 44, at which point it assumes its curvedshape, as shown in FIGS. 5A and 8. In some embodiments moving the slidebutton 51 proximally in handle 44 pushes the cover tube 60 distally. Insome embodiments moving the slide button 51 proximally in handle 44moves the catheter proximally to expose the distal end of the cover tube60. As illustrated in FIGS. 4A and 4B the slide button 51 can engagewith and be operatively connected to the catheter 42 with catheter slide57. In some embodiments the cover tube 60 is advanced until its distalend is adjacent to the vein wall at the desired point 65 (FIG. 9). Insome embodiments the cover tube 60 advances until its distal end abutsthe vein wall 66 at the desired point 65, as shown in FIG. 8. The stylet58 remains in cover tube 60.

The orientation of the extended cover tube 60 can be determined based onthe orientation of the handle 44. The slide button 51 engages with thetop portion 45A of the handle 44. The slide button 51, as illustrated inthe figures, is substantially perpendicular to a plane defined by theopposing wings 48 that extends along a length of the handle 44, e.g. theplane defined by the area where the top portion 45A of the handle 44contacts the bottom portion 45B of the handle 44. The cover tube 60extends upwards from the stylet lumen 50 and is also substantiallyperpendicular to the plane defined by the opposing wings 48 extendingalong a length of the handle 44. The positioning and orientation of thecover tube 60 after it has been advanced can also be visually verified,for example using fluoroscopy prior to deploying the stylet. The styletactuator is loaded by pulling proximally on a spring-load mechanism 52in handle 44, as shown in FIG. 5A. When slide button 51 is in itsproximal position shown in FIG. 5A, a stylet release button 53 isexposed. Depressing release button 53 advances stylet 58 distally underthe action of a spring 55 to the position shown in FIGS. 5B, 6A, 7A and9. The sharp distal tip penetrates the vein wall 66 at exit point 65,tissue 68 and skin 70 of the patient at the desired second entry point72, as shown in FIG. 9. The distance traveled by the stylet depends onthe application. For example, when the stylet is moving from the jugularvein wall through the patient's subdermal tissue and skin, the styletmay move 4 cm.

The guidewire 30 and cover tube 60 can also be used to securely positionthe device with a desired orientation in the vessel. The guidewire canextend from the distal end of the catheter 40 along one area of the veinwall 66. The guide tube 60 extends towards a vein wall 66 opposing thevein wall 66 that the guidewire extends along and in a substantiallyperpendicular orientation to the guidewire 30, as illustrated in FIG. 8.The vascular catheter 42 can be securely positioned and held in place bythe support from the guidewire 30 along one side of the vein wall 66 anda point of contact 65 between the guide tube 60 and another portion ofthe vein wall 66.

Various sizes can be used for the cover tube 60. The configuration ofthe pre-formed cover tube can be varied to use different shapes. Thelength and pre-formed configuration of the cover tube 60 can be selectedbased on the size of the vessel to be accessed.

In some embodiments the cover tube 60 is not fully extended from thevascular catheter 42. For example, the cover tube 60 may not be fullyextended to accommodate the specific geometry and size of vessel. Insmaller diameter blood vessels there may not be enough space to fullyextend the cover tube; however, the cover tube 60 and stylet 58 canproperly function partially extended from the vascular catheter.

In some embodiments, a smooth tapered wire cap 67 may be placed on thedistal end of stylet 58, and the stylet 58 may be tilted slightly at anangle, as shown in FIGS. 10 and 11. Catheter 42 and cover tube 60 maythen be withdrawn from its femoral entry point as the physician holdsstylet 58 in place. Next, the wire cap 67 is removed and then a centralline or micropuncture catheter 69 may then be passed over stylet 58 intovein 64, with the stylet acting as a guidewire for micropuncturecatheter 69. The stylet is then removed through either the exit locationor through the femoral entry point. In some embodiments a micropuncturecatheter 69 can be passed over the stylet 58 into vein 64 without theuse of a wire cap as illustrated in FIGS. 14-17.

Modifications of the invention will be apparent to those skilled in theart. Different lengths and diameters of catheter, cover tube and styletmay be used depending upon the application. The length of travel of thestylet and cover tube may also be varied. As an alternative to a rapidexchange guidewire arrangement, the catheter may have a guidewire lumenextending its entire length. The guidewire, cover tube and stylet mayalso share the same lumen.

The devices disclosed herein can be configured to access different typesof blood vessels and other hollow viscera including thebowel/intestine/gastrointestinal (GI) tract, ureter, bladder, airway,etc. In some embodiments the devices are used to access veins. In someembodiments the devices are used to access arteries. The devices can beintroduced to the vascular system at a first entry point. Examples offirst entry points include the femoral vein and femoral artery. Thedevices can be advanced to the desired target location for the formationof the second entry point. Examples of second entry points include thejugular vein, subclavian vein, carotid artery, axillary artery, andsubclavian artery. The stylet can be advanced through the blood vesselwall, tissue, and skin to form the second entry point. Multiple secondentry points can be formed at different locations. After formation ofthe second entry point a catheter or other medical device can beadvanced over the stylet for access to the vascular system at the secondentry point. Subsequent medical procedures can then be performed asdesired.

In some application multiple entry points may be desirable. The devicesdisclosed herein can be used to make multiple entry points. The stylet58 can be used to make a desired first entry point followed byintroducing a device for access at the first entry point such as acatheter, as shown in FIGS. 8-17. The vascular catheter 42 can bepositioned adjacent to a desired second entry point followed byadvancing the stylet 58 to form a second entry point. A catheter orother device can then be used to access the vessel at the second entrypoint. The process can be repeated to provide vascular access at thedesired number of locations.

Example 1

Animal testing was performed using the vascular catheter devicesdisclosed herein. The vascular catheter was introduced to the femoralvein at a first entry point. The catheter was advanced over a guidewireto the desired target location for forming the second entry point. Inone test the cover tube and stylet were deployed to puncture the veinwall, tissue, and skin at the jugular vein. An additional entry pointwas formed at the subclavian vein after forming the entry point in thejugular vein. In another procedure the vascular catheter was introducedinto the femoral artery as the first entry point. The catheter wasadvanced to the carotid artery where the cover tube and stylet weredeployed to form an entry point in the carotid artery. FIGS. 20A and 20Billustrate steps of the testing. FIG. 20A is a fluoroscopic image of adevice in accordance with an embodiment in an animal vein. FIG. 20B isan image of a device in accordance with an embodiment, including astylet after puncturing an animal vein.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined in part by the appended claims.

What is claimed is:
 1. A method of providing a second entry point in avessel of a patient remote from a first entry point, the methodcomprising: deploying a vascular guidewire into the vessel from thefirst entry point toward the second entry point, the first entry pointselected from the group consisting of: the femoral vein and femoralartery, and the second entry point selected from the group consistingof: the internal jugular vein, subclavian vein, carotid artery, axillaryartery, and subclavian artery; inserting the guidewire into a firstlumen of a vascular catheter; advancing the vascular catheter over theguidewire from the first entry point toward the second entry point;advancing a guide tube out of a distal end of a second lumen of thevascular catheter; directing a distal opening of the guide tube towardsa wall of the vessel at the second entry point; advancing a stylet outof the distal end of the guide tube, through the vessel wall and skin ofthe patient; and inserting a device over the stylet and into the vesselat the second entry point.
 2. The method of claim 1, wherein directingthe distal opening of the guide tube towards the wall of the vessel atthe second entry point includes placing the distal opening of the guidetube against the wall of the vessel at the second entry point.
 3. Themethod of claim 1 wherein the guide tube has a preformed curve at itsdistal end, the step of advancing the guide tube comprising permittingthe guide tube distal end to assume its preformed curve as the guidetube distal end is advanced out of the distal end of the second lumen ofthe vascular catheter.
 4. The method of claim 1 wherein the second lumenof the vascular catheter extends in a curve at its distal end, the stepof advancing the guide tube comprising engaging a camming surface in thecurve of the second lumen with a distal end of the guide tube to advancethe distal end of the guide tube away from a longitudinal axis of thevascular catheter and toward a wall of the vessel.
 5. The method ofclaim 1 wherein the step of advancing the guide tube comprises moving anactuator in a handle at the proximal end of the vascular catheter. 6.The method of claim 5, wherein moving the actuator advances the guidetube relative to the second lumen of the vascular catheter.
 7. Themethod of claim 5, wherein moving the actuator proximally retracts thevascular catheter relative to the guide tube.
 8. The method of claim 1wherein the step of advancing the stylet comprises operating a styletactuator in a handle at the proximal end of the vascular catheter. 9.The method of claim 8 wherein the step of operating an actuatorcomprises releasing a spring.
 10. The method of claim 9 furthercomprising loading the spring prior to the step of releasing the spring.11. The method of claim 1, further comprising verifying the positioningof the guide tube after placing the distal opening of the guide tubeagainst the wall of the vessel at the second entry point and prior toadvancing the stylet.
 12. The method of claim 11, wherein verifyingincludes using fluoroscopy to verify the position of the guide tube. 13.The method of claim 1, further comprising adjusting the orientation ofthe handle prior to advancing the guide tube to orient the vascularcatheter such that when the guide tube is advanced out of the distal endof the second lumen, the guide tube extends from the vascular cathetertowards the skin of the patient at the second entry point.